NCT05578651撤回不适用
A Prospective, Single Center, Observational Study to Assess the Rapid Recovery After Cardiac Surgery Using SternaLock XP
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Incidence of sternal wound infection
研究概览
简要总结
The primary objective of this study is to evaluate the post-operative rapid recovery in patients treated with SternaLock XP for rigid sternal fixation with sternal precautions less restrictive than standard of care.
详细描述
The primary efficacy endpoint of evaluation is defined by the post-operative time back to prior work or life through patient diary.
The primary safety endpoint of evaluation is defined by the incidence rate of sternal complications (DSWI & SSWI) at 30 days post-op.
The secondary endpoints of evaluation up to 60-days post-operative are defined by:
- Quality of recovery after surgery (QoR-15)
- Days alive out of the hospital and at home (DAH)
- Disability-free survival (WHODAS 2.0.)
- Pain scores: Likert scale 1-10
- Opioid pain medication usage
- Spirometry: inspiratory vital capacity (IVC), as a measure of lung function recovery
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female
- •≥ 18 years of age, no upper limit
- •Undergoing a full standard midline sternotomy as part of an elective or urgent cardiac surgical procedure [i.e., coronary artery bypass graft (CABG) and/ or valve replacement] and closed with the SternaLock XP Rigid Fixation System
- •Willing to sign Informed Consent prior to the cardiac surgical procedure
- •Willing and able to provide follow-up information up to 60-days post-operative
排除标准
- •Inclusion Criteria
- •Male and female
- •≥ 18 years of age, no upper limit
- •Undergoing a full standard midline sternotomy as part of an elective or urgent cardiac surgical procedure [i.e., coronary artery bypass graft (CABG) and/ or valve replacement] and closed with the SternaLock XP Rigid Fixation System
- •Willing to sign Informed Consent prior to the cardiac surgical procedure
- •Willing and able to provide follow-up information up to 60-days post-operative Exclusion Criteria
- •Pre-operative
- •Emergent or salvage cardiac acuity, i.e., patients undergoing cardiopulmonary resuscitation en-route to the operating room or prior to induction of anesthesia
- •Active or latent infection (with positive culture)
- •Documented foreign body sensitivity, allergy, or intolerance to metals.
- •Rapid bone absorption condition, metabolic bone disease, cancer, tumor, or tumor like condition of the bone, end-stage malignant disease, or other unexplained disease.
- •Mental/ neurologic conditions rendering patients unwilling or incapable of following post-operative care instructions.
- •Functional disability affecting gait, balance or mobility.
- •Delayed sternal closure required for any reason (e.g., sent to ICU with open chest wound)
- •Intra-operative conditions that, in the opinion of the operating surgeon, would preclude the use of rigid plate fixation.
- •Insufficient quantity of sternal bone or limited blood supply as assessed by the operating surgeon using his or her professional judgment at the time of closure.
- •Intraoperative death prior to device placement
结局指标
主要结局
Incidence of sternal wound infection
时间窗: 30 days
Rate of deep sternal wound infection and superficial sternal wound infection
次要结局
- Days alive and out of the hospital(60 days)
- Quality of recovery after surgery(60 days)
- Pain score(60 days)
- Opioid medication usage(60 days)
- Inspirometry vital capacity(60 days)
- Disability-free survival(60 days)
研究者
研究点 (1)
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